Euro Roundup: EMA starts first real-world evidence studies under DARWIN EU

RoundupsRoundups | 01 December 2022 |  By 

The European Medicines Agency (EMA) has begun the first real-world evidence (RWE) studies under its DARWIN EU initiative, kicking off three projects at the start of the “rapid ramp-up” of a program intended to support regulatory decision making.
DARWIN (Data Analysis and Real World Interrogation Network) EU is designed to give EMA, the European Commission and national competent authorities in the 27 member states access to the results of analyses of real-world healthcare databases. EMA named Erasmus University Medical Center Rotterdam as the DARWIN EU coordination center in February.
The first three studies will look at the epidemiology of rare blood cancers to understand their prevalence in Europe; the use of the teratogenic epilepsy drug valproate; and the use of antibiotics to inform future work on antimicrobial resistance. EMA will share more details of the studies, including their protocols, in the future.
Initially, DARWIN EU will rely on data from eight partners including the Clinical Practice Research Datalink GOLD at Oxford (UK) University and  and Bordeaux University Hospital, France. EMA selected the first batch of data partners according to its prioritization criteria, which favor organizations that have continuous data collection with at least annual data updates and a lag time of less than six months in data availability for analysis.
EMA wants to grow the program quickly in the coming years. The agency plans to add at least 10 new data partners every year and aims to scale up the research agenda to deliver around 150 RWE studies a year by 2025. 
Press Release
Swissmedic seeks feedback on ICH’s viral safety and clinical protocol guidelines
The Swiss Agency for Therapeutic Products (Swissmedic) has begun public consultations into two draft guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
One of the drafts covers viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. As Swissmedic notes, the draft features additional recommendations to reflect new biotechnology product types, advances in manufacturing technology, analytical methods for virus testing and scientific knowledge that have occurred since publication of the original document in 1999.
The recommendations cover established and complementary approaches to control the potential viral contamination of biotechnology products, including the selection and testing of cell lines and other raw materials, assessment of the capacity of the production process to clear infectious viruses and testing the product at appropriate steps of production. The consultation closes on 10 February.
Swissmedic also is seeking feedback on ICH’s draft guideline on the Clinical electronic Structured Harmonised Protocol (CeSHarP). Currently, there is no internationally adopted harmonized standard for the format and content of the clinical protocol. Establishing such a standard could support consistency in the development of structured and unstructured protocol content and provide a technical specification to facilitate its electronic exchange.
ICH’s draft has a template for the format and structure of the protocol, including the table of contents, common headers and contents, plus a technical specification that presents the conformance, cardinality and technical attributes to support the interoperable electronic exchange of protocol data. The CeSHarP draft is open for comment until 26 February.
Viral Notice, Protocol Notice
European Commission updates information for prospective reference laboratories
The European Commission has updated its information pack for candidate EU reference laboratories. Officials first published the pack in July to provide candidates with key information about the role of the laboratories and the selection process.
Since then, the Commission has added details, including a clarification that reference laboratories do not need to repeat performance studies carried out by manufacturers. Rather, they should devise “a suitable protocol to verify the performance and compliance with common specifications.” The protocol may involve a smaller sample size than that used by the manufacturer.
Officials have also added information about the independence and impartiality of reference laboratories. The text now states candidates that perform clinical or other lab services can continue to do so after becoming a reference laboratory “provided that there is a clear separation of EURL and clinical laboratory tasks.” For example, it would be a conflict of interest for a technical or scientific employee to use an in vitro diagnostic from a manufacturer in their clinical work and assess the device for the reference laboratory.
The Commission has also added a new section that describes financial viability checks, which explains member states responsible for candidate laboratories that are public institutions or part of public institutions must confirm how the organization is funded. 
Commission Update
MedTech Europe calls for ‘ambitious political initiatives’ to enable market access
MedTech Europe wants European authorities to start “ambitious political initiatives” to optimize their reimbursement and funding mechanisms for medical technologies.
The trade group made the request after working with Med Tech Reimbursement Consulting to map the reimbursement and funding of medical procedures and technologies in 32 countries. The work revealed each country has its own pathways, resulting in “a significant disparity” from market to market, and that innovative payment schemes for digital health technologies, devices and diagnostics are rare.
Austria, Belgium, England, France, Germany, the Netherlands, Spain and Switzerland have 21 innovative payment schemes between them. However, MedTech Europe notes that the existence of a scheme “is not automatically a guarantee of improved and timely access to medical technologies,” adding that the initiatives must be adequately designed, implemented and managed to achieve their goals.
Based on the findings, MedTech Europe wants stakeholders to work together to assess the strengths and weaknesses of existing payment schemes and “establish best practices for developing, implementing and running optimal schemes.”
Press Release
HPRA calls for manufacturer data to inform review of codeine’s regulatory status
Ireland’s Health Products Regulatory Authority (HPRA) has begun a formal regulatory procedure into the appropriate method of sale for medicines that contain codeine. Currently, such products are available over the counter in Ireland.
To inform its deliberations, the authority has asked marketing authorization holders to submit data that support the method of sale of their products. HPRA, which began the review earlier this year, will use the data gathered in the latest phase of the assessment to determine the steps it needs to take to ensure the safe and effective use of the medicines. The timeline will depend on the availability of third-party data.
The work is advancing in parallel to an EU safety review that was initiated by HPRA. The review looked at products that combine codeine and ibuprofen and resulted in recommendations to update the product information.
HPRA Notice
Other news:
The EU Innovation Network has launched the second phase of its simultaneous national scientific advice (SNSA) pilot. The pilot is aimed at applicants that want to obtain scientific advice from more than one national competent authority at the same time, and thereby improve the quality and consistency of the advice. SNSA’s second phase, which will run until the end of 2024, builds on an initial two-year pilot that received 33 requests for simultaneous scientific advice across multiple therapeutic areas. EMA Notice


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